Crystalline forms of atorvastatin

Abstract

The present invention is directed to new crystalline forms of Atorvastatin calcium (2:1), referred to hereinafter as polymorphic Forms X, A, B1, B2, C, D and E. Furthermore, the present invention is directed to processes for the preparation of these crystalline forms and pharmaceutical compositions comprising the crystalline forms.

1. A crystalline Form X of [R—(R*,R*)]-2-(4-fluorophenyl)-beta,delta-di-hydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid calcium salt having the PXRD spectrum substantially as depicited in  FIG. 1 . 
     
     
       2. A crystalline Form B1 of [R—(R*,R*)]-2-(4-flourophenyl)-beta,delta-di-hydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid calcium salt having the PXRD spectrum substantially as depicted in  FIG. 3 . 
     
     
       3. A crystalline Form B2 of [R—(R*,R*)]-2-(4-flourophenyl)-beta,delta-di-hydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid calcium salt having the PXRD spectrum substantially as depicted in  FIG. 3 . 
     
     
       4. A crystalline Form C of [R—(R*,R*)]-2-(4-flourophenyl)-beta,delta-di-hydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid calcium salt having the PXRD spectrum substantially as depicted in  FIG. 4 . 
     
     
       5. A crystalline Form D of [R—(R*,R*)]-2-(4-flourophenyl)-beta,delta-di-hydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid calcium salt having the PXRD spectrum substantially as depicted in  FIG. 5 . 
     
     
       6. A crystalline Form E of [R—(R*,R*)]-2-(4-flourophenyl)-beta,delta-di-hydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid calcium salt having the PXRD spectrum substantially as depicted in  FIG. 7 .